An Observational Post Marketing study to check the Safety and Effectiveness of Sofosbuvir based treatment in Patients with Chronic Hepatitis C

An observational, practice based, open label, prospective, multicenter, post marketing surveillance to assess safety and efficacy of sofosbuvir as a component of a combination antiviral treatment regimen for the treatment of patients with chronic hepatitis C (CHC) virus infection.

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/08/009547

Enrollment

500

Registered

2017-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- chronic hepatitis C (CHC) virus infection Health Condition 2: K739- Chronic hepatitis, unspecified

Interventions

Intervention1: Sofosbuvir 400 mg tablet: once daily as a component of a combination antiviral treatment regimen for 12/24 Weeks Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1. A written, signed and dated Data Sharing Informed Consent from all patients/LAR 2. Either gender with age 18 years and above 3. Patients having confirmed diagnosis of chronic hepatitis C virus infection who are either treatment naÃ¯ve or with prior treatment experience.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to Sofosbuvir or ribavirin or peginterferon alfa, daclatasvir or any of its components 2. Contraindications to Sofosbuvir or any of the components of the combination regimen 3. Women who are pregnant or may become pregnant and men whose female partners are pregnant 4. Women of child bearing potential who are unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator. 5. Any other condition as per the discretion of investigator

Design outcomes

Primary

Measure	Time frame
Percentage of patients achieving sustained virological response i.e. Maintenance of undetectable HCV RNA levels at the end of 12 weeks after completion of treatment (SVR12) Â· Percentage of patients achieving undetectable HCV RNA levels at end of 4 weeks of treatment â??rapid virological response (RVR)Timepoint: Percentage of patients achieving sustained virological response i.e. Maintenance of undetectable HCV RNA levels at the end of 12 weeks after completion of treatment (SVR12) Â· Percentage of patients achieving undetectable HCV RNA levels at end of 4 weeks of treatment â??rapid virological response (RVR)	—

Measure

Time frame

Percentage of patients achieving sustained virological response i.e. Maintenance of undetectable HCV RNA levels at the end of 12 weeks after completion of treatment (SVR12) Â· Percentage of patients achieving undetectable HCV RNA levels at end of 4 weeks of treatment â??rapid virological response (RVR)Timepoint: Percentage of patients achieving sustained virological response i.e. Maintenance of undetectable HCV RNA levels at the end of 12 weeks after completion of treatment (SVR12) Â· Percentage of patients achieving undetectable HCV RNA levels at end of 4 weeks of treatment â??rapid virological response (RVR)

—

Secondary

Measure	Time frame
Percentage of patients achieving sustained virological response i.e. Maintenance of undetectable HCV RNA levels at the end of 12 weeks after completion of treatment (SVR12) Â· Percentage of patients achieving undetectable HCV RNA levels at end of 4 weeks of treatment â??rapid virological response (RVR)Timepoint: 12 Weeks Post Treatment	—

Countries

India

Contacts

Public ContactDr Hiren Gandhecha

Accutest Research Laboratories (I) Pvt.Ltd

ajay.malle@accutestglobal.com02227780718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026